Kornimate/medical-research-clean huggingface dataset:
12-week-combined physical training in heart failure patients

Conditions: Heart Failure Patients

Summary: purpose: physical exercise exerts favorable impact on functional capacity (fc) and quality of life (ql) in patients with heart failure (hf). it is believed that the combined aerobic and resistance physical training (cpt) supervised by physical educator is better than only prescription of unsupervised exercise. the aim of this study is to compare the effects of a cpt program on the fc and ql of hf patients with reduced ejection fraction (hfref) with the practice medical routine prescription of regular physical activity and correlate these findings with clinical and echocardiographic variables. methods: a longitudinal prospective study included 28 consecutive hfref patients randomly divided in two age- and gender- matched groups: trained group (tg, n = 17), patients undergoing 12 weeks of supervised cpt and non trained group (ntg, n = 11), patients receiving only medical prescription to practice regular physical exercise. all patients were submitted to clinical evaluation, transthoracic echocardiography, cooper walk test and ql questionnaire before and after the study protocol. student t test or mann-whitney test were performed for groups comparison and correlation tests for the same group variable associations.


Eligibility criteria:
inclusion criteria: * patients with heart failure with lvef \<50%; * patients with optimized drug therapy; * age over 18 years. exclusion criteria: * heart failure nyha class iv and/or stage d; * decompensated hf in the last three months; * atrial fibrillation and/or implantable device at the moment of inclusion; * patients with chronic obstructive pulmonary disease (copd); * patients with biomechanical limitations of physical activity.

Keywords: exercise quality of life healthy cardiac remodeling
benefits of assistive listening device for speech intelligibility

Conditions: Hearing Loss

Summary: speech intelligibility in noise will be evaluated in adults with moderate to moderate-severe sensorineural hearing loss, using an assistive listening device and hearing aid, and compared to speech intelligibility in noise using hearing aids alone.


Eligibility criteria:
inclusion criteria: * adults age 18 or older with bilateral moderate to moderate severe sensorineural hearing loss, pure tone average must be between 40 and 69 db hl (decibel hearing level) * experienced hearing aid users * symmetric hearing loss (no more than 15 db difference between the ears at three contiguous frequencies) * good written and spoken english language skills * healthy outer ear as confirmed by otoscopy exclusion criteria: * contradictions to medical device noted upon otoscopy * known hypersensitivity or allergy to materials of investigational device or comparator * inability to produce reliable test results * known psychological problems * self reported symptoms of dizziness or vertigo
assessment of a femtosecond laser to perform capsulorhexis during cataract surgery

Conditions: Cataract Surgery

Summary: this study is a pre-market first-in-man clinical investigation to validate performance of a hand-held femtosecond laser named catsys.

interventional, prospective, longitudinal (follow-up: 30 ± 10 days), single-arm, single center, open trial. the "first-in-man" character of this investigation relies on the ergonomics of catsys (handpiece), and not on the laser technique, which is similar to other flacs. the purpose of the clinical investigation is to document the compliance of the investigational medical device with the general requirements of performance, safety and clinical benefit, in order to complete existing data and obtaining ce-mark for catsys.

Eligibility criteria:
inclusion criteria: * diagnosed with cataract requiring surgery according to current guidelines; * eligible to lens removal by phacoemulsification and replacement by a prosthetic lens under local anesthesia; * who have been informed and gave informed consent to participate in the study. exclusion criteria: * eye with an anterior chamber depth \ 3.8 mm; * corneal disease or pathology that precludes applanation of the cornea or transmission of laser wavelength or distortion of laser light; * eye with a poorly dilating pupil or other defect of the pupil that prevents the iris from adequate retraction peripherally; * patient with residual, recurrent, active ocular or eyelid disease, including any corneal abnormality (for example, recurrent corneal erosion, severe basement membrane disease) in either eye; * history of steroid-responsive rise in iop, glaucoma, or preoperative iop\>21 mm hg in either eye; * lens/zonular instability such as, but not restricted to, marfan's syndrome, pseudoexfoliation syndrome, etc; * previous intraocular or corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes in either eye; * any recent penetrating incision of the eyeball; * tilt of lens \> 7; * presence of any obstacle that may interfere with the stabilization of the device on the limbus: pterygium, limbic tumor, etc; * pregnant or lactating woman; * patient with any contra-indication to neosynephrine, tropicamide and oxybuprocaïne; * patient presenting any contraindications to cataract surgery under local anesthesia (ex: allergy to anesthetic drops; neurodegenerative disease; schizophrenia; severe anxiety; etc.); * patient who participates to another clinical trial (except observational studies), or in the exclusion period of another clinical trial; * patient under guardianship, trusteeship or deprived of liberty; * patient not affiliated to the french social security system; * patient unable to participate in the study for psychiatric, cognitive or linguistic reasons.
comparison of empagliflozin and dapagliflozin in patients with heart failure taking standard treatment

Conditions: Diabetes Mellitus; Heart Failure

Summary: participants were enrolled and randomly divided in two groups. in group a, participants were prescribed dapagliflozin 10 mg daily. in group b, participants were prescribed empagliflozin 10 mg daily. all participants were followed-up in opd after 12 weeks for assessment of ejection fraction.

this study's rationale is to examine the effects of dapagliflozin and empagliflozin on heart failure in patients receiving arni and sglt2. research revealed that the two medications results are identical. although the cardiac functioning improved better with empagliflozin. but limited data has been available in this regard, while no local trial conducted before. thus, in routine sglt2 and arni are given to control glycemic level and maintain cardiac functioning. however, addition of empagliflozin and dapagliflozin can be more beneficial in improving cardiac functioning and reducing adverse events. therefore the investigators planned to conduct this study to get evidence in local population. this will help to improve practice.

Eligibility criteria:
inclusion criteria: * patients aged 40-60 years of either gender diagnosed with heart failure ( heart failure was defined as presence of ejection fraction \<50% on echocardiography, with pedal edema, water in lungs, paroxysmal nocturnal dyspnea or exertional limitation due to failure of ventricular fillings) * diabetic patients, with hba1c\>6.5% for \>1 year already taking sglt-2 and arni inhibitor. exclusion criteria: * patients already had valvular device, mitral or aortic valve regurgitation or stenosis detected on echocardiography, heart transplantation, chronic renal failure or dialysis patients, cardiomyopathy, liver failure or malignancy. * patients already taking trial drugs or other anti-glycemic or cardiac medication.

Keywords: ejection fraction angiotensin receptor neprilysin inhibitor dapagliflozin empagliflozin
dexmedetomidine vs. propofol for cataract surgery

Conditions: Cataract

Summary: the use of dexmedetomidine in cataract surgery is still limited and to date only one study has examined anesthetic technique in this patient population. this pilot study will therefore compare the use of dexmedetomidine and propofol in subjects undergoing cataract surgery. the primary endpoint will be based on simple cardiorespiratory measures often associated with complications from sedation as well as assessment of the achieved sedation by the attending anesthesiologist and surgeon.


Eligibility criteria:
inclusion criteria: 1. normal renal function 2. no chronic use of narcotics 3. asa ps1-3 4. males or females age 18 or older exclusion criteria: 1. liver disease (child pugh classification 1-3) 2. history of chronic use of sedatives, narcotics, alcohol or illicit drugs or allergy to any the study medications 3. history of 1st and 2nd degree heart block (not paced) 4. any patient with ef \< 30% 5. patients with active seizure history 6. pregnant patients (women of child bearing potential will have a preoperative pregnancy test as is standard of practice)

Keywords: propofol dexmedetomidine cataract respiratory blood pressure cataract surgery
acupuncture pilot study for cancer-related cognitive function

Conditions: Stage I Breast Cancer; Stage II Breast Cancer; Stage III Breast Cancer; Stage I Colorectal Cancer; Stage II Colorectal Cancer; Stage III Colorectal Cancer; Gynecologic Cancer; Stage I Gynecologic Cancer; Stage II Gynecologic Cancer; Stage III Gynecologic Cancer; Stage I Prostate Cancer; Stage II Prostate Cancer; Stage III Prostate Cancer

Summary: this study is being done to explore whether acupuncture can improve cognitive difficulties in patients diagnosed with cancer.


Eligibility criteria:
inclusion criteria: * english-speaking * age 18 ≥ years old * diagnosis (breast, colorectal, prostate or gynecological cancer) * completed initial cancer treatment (surgery, chemotherapy, and/or radiation therapy) at least one month prior to study enrollment (patients receiving maintenance cancer treatment with hormonal or targeted therapies are permitted) * must report moderate or greater perceived cd as indicated by a score of "quite a bit" or "very much" on at least one of the two items that specifically assess concentration (item #20) and memory (item #25) on the eortc qlq-c30 instrument (version 3.0) * must indicate that their cognitive functions have worsened since their cancer diagnosis by replying "yes" to all of the following questions: * do you think or feel that your memory or mental ability has gotten worse since your cancer diagnosis? * do you think your mind isn't as sharp now as it was before your cancer diagnosis? * do you feel like these problems have made it harder to function on your job or take care of things around the home? * must be willing to adhere to all study-related procedures, including randomization to one of the 2 possible choices: acupuncture or sham acupuncture exclusion criteria: * active disease * use of acupuncture for cognitive symptom management within the past 3 months * diagnosis of alzheimer's disease, vascular dementia, parkinson disease, or other organic brain disorder * score of ≥10 on the blessed orientation-memory-concentration (bomc) screening instrument * primary psychiatric disorder not in remission * initiation or change in medication (e.g., hypnotics, sedatives, and/or antidepressants) in the past 8 weeks

Keywords: breast cancer colorectal cancer gynecologic cancer acupuncture memorial sloan kettering cancer center 19-179 prostate cancer
study of the efficacy of estratest® h.s. tablets in relieving menopausal symptoms in estrogenized postmenopausal women

Conditions: Menopause

Summary: to determine whether treatment with estratest® h.s. tablets is superior to treatment with esterified estrogens tablets


Eligibility criteria:
inclusion criteria: menopausal women between the ages of 30 and 65 years (inclusive) with symptoms of estrogen and/or androgen deficiency not currently controlled by estrogen therapy as determined by patient report and the investigator's clinical judgement

Keywords: menopause; postmenopause; estrogen; hormone therapy
pharmacist-led perioperative medicines optimisation

Conditions: Parkinson Disease

Summary: patients attend pre-assessment clinics (poac) who require an elective operation and who are having a general anaesthetic. at poac patients are asked about their health, and past medical conditions to assess their fitness for anaesthetic, a list of medicines taken is documented. patients can then be given a date for surgery. during their stay in hospital patients will see a pharmacist who confirms what medicines are being taken, and ensures those medicines are prescribed and available during the patients stay. this study is aimed at improving the care of patients who are admitted for elective surgery. the study will review two different interventions made prior to a patient's admission for surgery. one will look at a group of patients taking a high risk medicine and the other a group of patients with a high risk disease. the high risk medicine chosen is warfarin, and the high risk disease is parkinson's disease. it is known that inappropriate or lack of medicines management in these groups can result in delayed surgery, poorer surgical outcomes and can affect a patient's recovery after surgery. due to patient numbers and the variability between patients being too great, and a lack of research in this area a controlled trial cannot be performed. this complex intervention will review the interventions made, to understand how and why the interventions change care and what it is specifically within the interventions that are exerting a positive effect to improve care. all elective surgical patients who attend poac at st james' university hospital who are either, taking warfarin or who have parkinson's disease will be seen by a pharmacist. an accurate drug history will be taken and if changes are required to medications these will be resolved at the poac appointment. patients will be provided with an individualised perioperative medication plan.


Eligibility criteria:
inclusion criteria: * participant has capacity. * participants must be attending the poac at st james' university hospital * scheduled elective surgery or other procedures requiring general anaesthesia * male or female, aged 18 years or above. * diagnosed with parkinson's disease or taking warfarin * in the investigator's opinion, is able and willing to comply with all requirements of the intervention. exclusion criteria: * female participant who is pregnant, lactating or planning pregnancy during the course of the intervention. * under 17years of age * participants who are having a local anaesthetic * any who are having emergency surgery * participants who are unable to provide consent * any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk or may influence the result, or the participant's ability to participate in the intervention.
quetiapine augmentation for treatment-resistant ptsd

Conditions: Combat Disorders; Stress Disorders, Post-Traumatic

Summary: the purpose of this study is to compare the response of veterans with ptsd without an optimal response to paroxetine to quetiapine augmentation versus placebo.

this is a two-site study designed to evaluate the efficacy and safety of quetiapine augmentation of paroxetine treatment in veterans with ptsd who have failed to respond to paroxetine treatment. in phase i, eligible patients will take open-label paroxetine (up to 60 mg daily) for 8 weeks. patients who are refractory (less than 30% reduction in caps scores or a minimum caps score of 50 at week 8) and have ptsd symptoms of at least moderate severity on cgi-s will be eligible for the second phase. in phase ii, patients will continue taking open-label paroxetine and will be randomized to the addition of quetiapine (up to 800 mg daily) or placebo for 8 weeks in a double-blind fashion.

Eligibility criteria:
inclusion criteria: * veteran age 18 to 75. * competent to give informed consent. * meeting dsm-iv criteria for ptsd. * minimal caps score of 50 at baseline. * if female of childbearing potential, patient must have a negative pregnancy test and, if sexually active, be using a medically approved contraceptive method. * patients who have not taken psychiatric medications within 1 week prior to study entry (except fluoxetine \[5 weeks\]) * monoamine oxidase inhibitors (maois \[4 weeks\]) * depot neuroleptics \[4 weeks\]) * or any investigational drug within 30 days prior to study enrollment. * to be eligible for phase ii * patients must be refractory to paroxetine in phase i, as defined by less than 30% reduction in caps scores or a minimum caps score of 50 at week 8 * must have ptsd symptoms at least moderate severity on cgi-s * and must have been compliant with study medicine in phase i, as defined by taking at least 80% of prescribed doses. exclusion criteria: * history of sensitivity to paroxetine or quetiapine. * failure to respond to a prior adequate therapeutic trial i.e. minimum of 8 weeks at maximum tolerated dose of paroxetine (up to 60 mg daily) or quetiapine (up to 800 mg daily). * women who are * breast-feeding * pregnant * expect to become pregnant during the course of the study * or are sexually active and are not using a medically acceptable method of birth control. * presence of clinically significant hepatic * cardiovascular * or other medical conditions that may prevent safe administration of paroxetine or quetiapine * or any other clinically significant unstable medical conditions.

Keywords: atypical antipsychotics controlled trial paroxetine quetiapine stress disorders, post-traumatic treatment refractory treatment resistant
relevance of the ethanol dose in the generation of endogenous hydroxytyrosol

Conditions: Contribution of Ethanol on Hydroxytyrosol Formation

Summary: health benefits for humans derived from low dose intake of ethanol could partially be explained by its interaction with dopamine (da) oxidative metabolism. ethanol is expected to induce an increase in the formation of a da minor metabolite: dopet (hydroxytyrosol). hydroxytyrosol is one of the most potent antioxidants present in mediterranean diet. the study is aimed at establishing the contribution of ethanol on hydroxytyrosol formation.


Eligibility criteria:
inclusion criteria: * clinical history and physical examination demonstrating no organic or psychiatric disorders. * the ecg and general blood and urine laboratory tests performed before the study should be within normal ranges. minor or occasional changes from normal ranges are accepted if, in the investigator's opinion, considering the current state of the art, they are not clinically significant, are not life-threatening for the subjects and do not interfere with the product assessment. these changes and their non-relevance will be justified in writing specifically. * the body mass index (bmi=weigh/height2) will range from 19 to 27 kg/m2, and the weight from 50 to 110 kg. * understanding and accepting the study procedures and signing the informed consent. exclusion criteria: * not meeting the inclusion criteria. * history or clinical evidence of alcoholism, drug abuse, or regular use of psychoactive drugs. * having suffered any organic disease or major surgery in the three months prior to the study start. * history of psychiatric disorders. * smokers of more than 20 cigarettes per day. * taking more than 30 g of alcohol a day * regular use of any drug in the month prior to the study sessions.the treatment with single or limited doses of symptomatic medicinal products in the week prior to the study sessions will not be a reason for exclusion if it is calculated that it has been cleared completely the day of the experimental session. * blood donation 8 weeks before or participation in other clinical trials with drugs in the previous 12 weeks. * subjects with intolerance or adverse reactions to ethanol * history or clinical evidence of gastrointestinal, liver, renal or other disorders which may lead to suspecting a disorder in drug absorption, distribution, metabolism or excretion, or that suggest gastrointestinal irritation due to drugs. * subjects unable to understand the nature, consequences of the study and the procedures requested to be followed. * subjects with positive serology to hepatitis b, c or hiv. to be eligible, the subjects must agree to follow a diet free from ethanol and olive oil in the 72 hours prior to the start of each session and until the end of the study.

Keywords: antioxidants, central nervous system agents
measuring cortisol levels in persons with parkinson's (pd)

Conditions: Parkinson Disease; Huntington Disease

Summary: the objective of this study is to evaluate the cortisol awakening response with persons with parkinsons disease (pd), huntingtons disease (hd), and controls. these data are desired so experience can be gained with measuring stress levels subjectively and objectively in persons with pd, hd, and controls.

telephone consent will be obtained. participants will collect saliva at twelve time points - four times a day for three days. visits will be conducted virtually (over the internet). the virtual visit is to assess parkinson's or huntington's disease status, stress, mood, and quality of life.

Eligibility criteria:
inclusion criteria: group (3) inclusion: * no significant neurological disorder * pss score of greater than or equal to 13. group (5) inclusion: * hd diagnosis or hd gene carrier * a perceived stress scale (pss) score higher than or equal to 13. group (6) inclusion: * hd diagnosis or hd gene carrier * pss score lower than 13 group (7) inclusion: * pd diagnosis * prior completion of the study. exclusion criteria: * the use of medications known to effect cortisol levels (estrogen, synthetic glucocorticoids, androgens, phenytoin, spironolactone, prednisone, prednisolone, and hydrocortisone).

Keywords: movement disorders metabolic stress basal ganglia disorders
assessment of early-detection based on liquid biopsy in hepatobiliary cancer malignancies

Conditions: Hepatobiliary Malignancies

Summary: this study is a prospective, multicenter study aimed to develop and validate the performance of combined assays for cfdna methylation markers and serum tumor markers in early hepatobiliary malignancies detection. circulating tumor dna (ctdna) mutation, blood rna markers and tissue will also be evaluated. the study will enroll approximately 496 participants, including participants with malignant or benign diseases of the hepatobiliary system.


Eligibility criteria:
inclusion criteria for all the participants: * 40-75 years old * ability to comply with study procedures * ability to provide a written informed consent exclusion criteria for all the participants: * pregnancy or lactating women * recipients of organ transplant or prior non-autologous (allogeneic) bone marrow transplant or stem cell transplant * recipients of blood transfusion within 7 days prior to study blood draw * recipients of anti-microbial therapy within 14 days prior to study blood draw * recipients of any anti-cancer therapy within 30 days prior to study blood draw, due to diseases other than cancer inclusion criteria for cancer arm participants: * confirmed diagnosis or highly suspicious cases of hepatobiliary malignancies * no prior or ongoing anti-cancer therapy (local or systematic) prior to study blood draw exclusion criteria for cancer arm participants: * current diagnosis of other malignancies or multiple primary tumors * diagnosis of benign diseases by histopathological assessments * inability to characterize whether the lesion is malignant or benign * prior or ongoing treatment of cancer inclusion criteria for benign diseases arm participants: * confirmed diagnosis of benign diseases of the hepatobiliary system * no prior radical treatment of the benign diseases prior to study blood draw exclusion criteria for benign diseases arm participants: * current or history of malignancies or precancerous lesions * no confirmed diagnosis or inability to characterize a benign disease

Keywords: hepatobiliary malignancies liquid biopsy cell-free dna early detection